HCV New Drugs: Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)

Showing posts with label Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir). Show all posts

Sunday, November 11, 2018

Liver Meeting® 2018 - SOF/VEL/VOX Successful for Hepatitis C Virus Retreatment in Patients With and Without HIV

The Liver Meeting® 2018

San Francisco, CA.

November 9-13, 2018

Meeting Coverage

MD Magazine
On Twitter
@MDMagazine

SOF/VEL/VOX Successful for Hepatitis C Virus Retreatment in Patients With and Without HIV

NOVEMBER 10, 2018
Danielle Mroz

Treatment was also successful in patients with prior noncompletion or poor adherence to direct-acting antiviral therapy.

A fixed-dose combination therapy of sofosbuvir, velpatasvir, and voxilaprevir (SOF/VEL/VOX, Vosevi, Gilead) was highly effective after 12 weeks in retreating direct-acting antiviral-experienced patients with hepatitis C virus infection, with and without HIV co-infection, including those with prior noncompletion of treatment or poor adherence, according to results of a new study.

Read More: https://www.mdmag.com/conference-coverage/aasld-2018/sofvelvox-successful-for-hepatitis-c-virus-retreatment-in-patients-with-and-without-hiv

Meeting Updates

View all updates on this blog, (LINK), coverage elsewhere, (LINK).

Wednesday, October 10, 2018

Hepatitis C - Vosevi safe, effective in ‘triple-infected’ patients with HCV, HBV, HIV

Vosevi safe, effective in ‘triple-infected’ patients with HCV, HBV, HIV

PHILADELPHIA – The direct-acting antiviral Vosevi demonstrated an average sustained virologic response rate of 87% among patients who were “triple-infected” with hepatitis C genotype 3, hepatitis B and HIV, as presented at the American College of Gastroenterology Annual Meeting.

“Chronic hepatitis C treatment is no longer challenging in the era of DAAs with an SVR of up to 97%. However, triple infection treatment with HCV, HIV and hepatitis B has not been explored in real life situations,” Nimy John, MD, from the University of Massachusetts Medical School, said during her presentation.

Read the article:
https://www.healio.com/gastroenterology/hepatitis-c/news/online/%7B48f981a3-e83f-4e70-8c39-4acd467af6f7%7D/vosevi-safe-effective-in-triple-infected-patients-with-hcv-hbv-hiv

Healio Coverage:

American College of Gastroenterology Annual Meeting
October 5, 2018 - October 10, 2018
See more from American College of Gastroenterology Annual Meeting

Thursday, July 12, 2018

Challenges and perspectives of direct antivirals for the treatment of hepatitis C virus infection

Journal of Hepatology
Challenges and perspectives of direct antivirals for the treatment of hepatitis C virus infection

JohannesVermehren, James S. Park, Ira Jacobson, StefanZeuzem

https://doi.org/10.1016/j.jhep.2018.07.002

Full-Text

PDF Download

Follow On Twitter

The following full-text articles downloaded and shared by Henry E. Chang.

Abstract

Treatment of chronic hepatitis C virus (HCV) infection has been revolutionized with the development of direct-acting antiviral agents (DAAs). Eight to twelve weeks of all-oral, once-daily treatments is now the standard of care and viral eradication can be achieved in >95% across different patient populations. Despite these advances, several unresolved issues remain, including treatment of HCV genotype 3, chronic kidney disease, and in patients in whom DAA therapy has failed. Glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) are the most recently approved DAA regimens. Given the overwhelming success of modern DAA-based therapies, GLE/PIB and SOF/VEL/VOX are also likely to represent the last DAAs to be approved. Both are pangenotypic, once-daily, all-oral DAA combinations that have the potential to close the gaps in the current DAA treatment portfolio. Here, we review the challenges associated with current DAAs and how these two regimens may be implemented in existing treatment algorithms.

Continue to article: https://jumpshare.com/v/UyqlFMHW9EjHQW9vWFYJ

Of Special Interest
Commentary
Hepatitis C Management Simplification From Test to Cure:A Framework for Primary Care Providers
SOF/VEL or GLE/PIB), both highly tolerated and effective for all genotypes.

Sofosbuvir and Ledipasvir is Associated with High Sustained Virologic Response and Improvement of Health-Related Quality of Life in East Asian Patients with Hepatitis C Virus Infection
In summary, our data clearly show the superiority of IFN-free RBV-free LDV/SOF in East Asian patients with chronic HCV genotype 1 infection. The advantages of that regimen are related not only to its high efficacy and excellent tolerability but also to significantly better quality of life during treatment and after achieving SVR. These data provide evidences up porting the comprehensive benefit of LDV/SOF for eligible patients which should inform all stakeholders, including providers, payers, and policy makers in East Asian countries

Absolute Insurer Denial of Direct-Acting Antiviral Therapy for Hepatitis C: A National Specialty Pharmacy Cohort Study

Absolute denials of DAA regimens by insurers in the U.S. have remained high & increased over time, regardless of type of insurance.

Monday, May 7, 2018

Where the latest HCV drug combos fit in

Where the latest HCV drug combos fit in
Publish date: May 6, 2018

His copanelist Norah Terrault, MD, agreed that these two regimens are important additions.

“Glecaprevir/pibrentasvir is the first pangenic 8-week regimen for noncirrhotics. This is a major advance. And now having sofosbuvir/velpatasvir/voxilaprevir for treatment-experienced patients, that’s another strong advance,” commented Dr. Terrault, professor of medicine and director of the Viral Hepatitis Center at the University of California, San Francisco.

Article: https://www.mdedge.com/internalmedicinenews/article/164992/infectious-diseases/where-latest-hcv-drug-combos-fit/page/0/1

Saturday, March 24, 2018

Patient-Reported Outcomes After HCV Treatment With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir

This is an extensive evaluation of Patient-Reported Outcomes (PROs) during and after treatment with 2 pangenotypic regimens for HCV. Our data clearly show that both regimens improve several PRO scores shortly after initiation of treatment. This improvement in PROs persisted throughout treatment and was even more considerable after achieving SVR-12. Moreover, the gains in PROs were not only sustained 12 weeks post-treatment but continued to further improve by Week 24 of follow-up.

Clinical Gastroenterology and Hepatology

April 2018 Volume 16, Issue 4, Pages 567–574.e6

Patient-Reported Outcomes Following Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir

Young-A HeoEmail authorEmma D. Deeks

Background & Aims
Chronic infection with hepatitis C virus (HCV) has many hepatic and extrahepatic manifestations, measured by patient-reported outcomes (PROs). We measured changes in PROs during HCV treatment with recently developed pangenotypic regimens and from a sustained virologic response 12 weeks after treatment ended (SVR12).

Methods
We collected PRO data from 2 multi-center, blinded, international phase 3 trials of sofosbuvir, velpatasvir, and voxilaprevir, from 748 patients previously treated with direct-acting antivirals for chronic infection with HCV of any genotype (59% HCV genotype 1, 43% with compensated cirrhosis) (POLARIS-1 and POLARIS-4). The combination of sofosbuvir, velpatasvir, and voxilaprevir was given to 445 patients, the combination of sofosbuvir and velpatasvir to 151 patients, and placebo to 152 patients. Patients completed the SF-36, FACIT-F, CLDQ-HCV, and WPAI:SHP questionnaires at baseline, during treatment, and during the follow-up period.

Results
There was no difference in baseline clinical or demographic features or PRO scores among the groups (all P > .05). The group that received the combination of sofosbuvir, velpatasvir, and voxilaprevir had more gastrointestinal symptoms than the groups that received sofosbuvir and velpatasvir or placebo (P = .0001). An SVR12 was achieved by 90.1% of patients who received sofosbuvir and velpatasvir vs 96.9% of patients who received sofosbuvir, velpatasvir, and voxilaprevir (P = .0008). After 12 weeks of treatment, some PRO scores improved in both treatment groups (by 2.5 or by 9.1 points, on a 0–100 scale; P < .05) but not in the placebo group. All increases in PRO scores were sustained or increased after treatment ended (an increase of up to 11.1 points at 12 weeks after treatment and an increase of up to 16.6 points at 24 weeks after treatment ended) (P < .05 for all but 2 PROs). There were no differences in PROs between the sofosbuvir and velpatasvir group vs the sofosbuvir, velpatasvir, and voxilaprevir group (all P > .05). In multivariate analysis, after adjustment for clinical and demographic factors and baseline PRO scores, receiving treatment was associated with higher PROs scores than receiving placebo (beta as high as 5.1) (P < .05).

Conclusions
In an analysis of data from 2 phase 3 clinical trials of patients with chronic HCV infection of any genotype, we found the combination of sofosbuvir, velpatasvir, with or without voxilaprevir, to increase PRO scores compared with placebo. These findings indicate the comprehensive benefit of these regimens during treatment and after SVR.

Discussion
Download Full-Text
View Online
This is an extensive evaluation of Patient-Reported Outcomes (PROs) during and after treatment with 2 pangenotypic regimens for HCV. Our data clearly show that both regimens improve several PRO scores shortly after initiation of treatment. This improvement in PROs persisted throughout treatment and was even more considerable after achieving SVR-12. Moreover, the gains in PROs were not only sustained 12 weeks post-treatment but continued to further improve by Week 24 of follow-up.

We believe that initial gains in PROs are related to viral suppression that can occur with both regimens. Indeed, no similar improvement was seen in subjects who received placebo in a blinded fashion. In addition, unlike previously studied interferon + ribavirin-containing and interferon-free ribavirin-containing regimens, which resulted in decrements in PROs during treatment and weeks after treatment cessation,¹⁸^, ²² no treatment-emergent PRO decrements were observed in actively treated patients in this study. Furthermore, presented PRO gains were similar to those reported for other all-oral interferon- and ribavirin-free regimens regardless of their duration.⁸^, ¹⁵^, ¹⁶^, ²⁰^, ²¹^, ²³ This suggests that patients’ experience was not adversely affected by the side effects of the studied regimens and supports excellent tolerability of these regimens for HCV treatment.

In addition to the PRO benefit during treatment, the data clearly show that achieving SVR leads to sustainable gains in PROs, again consistent with previous reports for other DAA-based regimens.⁹^, ¹⁰^, ¹¹^, ¹²^, ¹³^, ¹⁴^, ¹⁵^, ¹⁶^, ¹⁷^, ¹⁸^, ¹⁹^, ²⁰^, ²¹^, ²²^, ²³ The magnitudes of post-SVR PRO improvements suggest their clinical relevance because most PROs increased by more than 3%–5% of a PRO range size, which is believed to be the minimal clinically important difference in PROs.³⁸^, ³⁹

Furthermore, such improvements are comparable with long-term improvements in PRO scores observed in patients who had cardiac bypass surgery for their coronary artery disease or patients with rheumatoid arthritis after 24 weeks of treatment with methotrexate.⁴⁰^, ⁴¹ Accompanied by high efficacy of SOF/VEL ± VOX regimens, these PRO data provide support to the comprehensive benefit (to include clinical, or SVR, and patients’ experience, or PROs) of these new regimens for HCV-infected patients.

Finally, we have confirmed that the presence of cirrhosis, fatigue, and psychiatric comorbidities contributes to impaired PROs in patients with HCV; this is consistent with similar findings from prior studies.⁹^, ¹⁰^, ¹¹^, ¹²^, ¹³^, ¹⁴^, ¹⁵^, ¹⁶^, ¹⁷^, ¹⁸^, ¹⁹^, ²⁰^, ²¹^, ²²^, ²³ Although the exact causes of the observed association of location with baseline PROs are unclear, this is also consistent with prior reports on the contribution of cultural and ethnic factors to various PRO measures.⁴²^, ⁴³ Nevertheless, the sociodemographic reasons for this difference requires future investigation. Furthermore, our multivariate analysis clearly shows that receiving active treatment with SOF/VEL or SOF/VEL/VOX is independently and similarly associated with improvement of PROs during treatment and in post-treatment follow-up. It is important to note, however, that other major predictors of greater on-treatment and post-treatment PRO gains were factors associated with lower baseline scores, such as history of depression, anxiety, and clinically overt fatigue, suggesting that these conditions, potentially associated with the extrahepatic manifestations of HCV, may also potentially resolve with virologic clearance; further prospectively designed studies are needed to confirm this hypothesis.

The main limitation of this study is the setting where PRO data were collected. Given that the PRO improvements were documented in the clinical trials setting, similar data from real-world clinical practices are needed; this issue applies both to clinical outcomes and PROs. Other limitations include open-label design of POLARIS-4, which might have affected PROs in participants; limited follow-up duration; and the lack of data on other potentially important PRO predictors, such as patients’ education, family status, and other socioeconomic parameters.

In summary, our study assessed the effect of 2 anti-HCV regimens, SOF/VEL and SOF/VEL/VOX, on PRO scores. The data are supportive of the comprehensive benefit of the new all-oral pangenotypic regimens for patients infected with HCV who had failed another DAA-based regimen and might have been left with no treatment options otherwise.
Continue to article: http://www.cghjournal.org/article/S1542-3565(17)31360-5/fulltext

Contact hcvnewdrugs@gmail.com

Helpful Links
HCV Education
Research Articles
Fibrosis
Cirrhosis
Liver Cancer
Liver Transplants
Fatty Liver Disease
HCV-elderly
Possible Side Effects Of HCV Therapy
Other Conditions Related To HCV
HCV Genotypes/treatment
HCV Newsletters
Premier Hepatitis C Websites

The above links offer data about interferon-free regimens approved to treat HCV, with learning activities, editorials, and tips from patient bloggers who understand the ups and downs of liver disease, in addition to a list of outstanding hepatitis C websites, blogs and support forums.

On Twitter
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading articles about the treatment and management of hepatitis C.

The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Latest Update Feb 12, 2019

Lancet Study:

Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C

These findings firmly counter those of a Cochrane review of direct-acting antiviral treatment trials that could neither confirm nor reject if direct-acting antivirals had an effect on long-term HCV-related morbidity and mortality. They also provide the best evidence to date to support guidance documents that recommend direct-acting antiviral treatment for all patients with chronic HCV infection.

The Controversy
Rebuttal over Cochrane Review of DAAs
A systematic review published by the Cochrane Collaboration suggested achieving SVR (cure) for patients using hepatitis C direct-acting antivirals (DAAs) doesn't correlate with any long term benefits. View each rebuttal and all ongoing media coverage.

Risk Of Developing Liver Cancer After HCV Treatment